
[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Rules and Regulations]
[Pages 66651-66653]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26364]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0583; FRL-9401-9]


Imazapyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
imazapyr in or on lentil at 0.2 parts per million (ppm); and rapeseed 
subgroup 20A and sunflower subgroup 20B at 0.05 ppm. BASF Corporation 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective November 6, 2013. Objections and 
requests for hearings must be received on or before January 6, 2014, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0583, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2012-0583 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
January 6, 2014. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified

[[Page 66652]]

by docket ID number EPA-HQ-OPP-2012-0583, by one of the following 
methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of August 22, 2012 (77 FR 163) (FRL-9358-
9), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
2E8045) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 
27709. The petition requested that 40 CFR 180.500 be amended by 
establishing tolerances for residues of the herbicide, imazapyr [2-
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-3-
pyridinecarboxylic acid], in or on lentil at 0.2 ppm; and rapeseed 
subgroup 20A and sunflower subgroup 20B at 0.05 ppm. That document 
referenced a summary of the petition prepared by BASF Corporation, the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    EPA has revised the tolerance expression to clarify the chemical 
moieties that are covered by the tolerances and specify how compliance 
with the tolerance is to be measured. The reason for this change is 
explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for imazapyr including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with imazapyr follows.
    In 2003, EPA quantitatively assessed the risk of imazapyr 
tolerances in connection with the final rule published in the Federal 
Register of September 26, 2003 (68 FR 55475) (FRL-7321-4) establishing 
tolerances for imazapyr in or on grass, forage; grass, hay; fish; 
shellfish; fats of cattle, sheep, goats, and horses; kidney of cattle, 
sheep, goats, and horses; meat byproducts (except kidney) of cattle, 
sheep, goats, and horses; meat of cattle, sheep, goats, and horses; and 
milk. At that time, EPA determined that the aggregate risks from 
exposure to imazapyr were minimal. In reviewing the current tolerance 
petition, EPA determined that the toxicity database for imazapyr is 
complete and no additional studies are needed. EPA also determined that 
the toxicity data identified no hazard from imazapyr regardless of the 
route of exposure or the species tested. In the absence of evidence of 
neurotoxicity, immunotoxicity, genotoxicity, carcinogenicity, or other 
acute or chronic toxicity in conjunction with no adverse developmental 
or reproductive effects, the Agency concluded that a quantitative risk 
assessment for imazapyr was no longer needed and that EPA could 
determine based on a qualitative assessment of the imazapyr database 
that the proposed import tolerances are safe. This conclusion is 
supported by the findings in the last risk assessment, which were based 
on conservative (protective) toxicity endpoints showing only negligible 
aggregate exposures and risks identified from dietary, residential, and 
swimming and occupational routes. As previously indicated, EPA has 
determined that this prior quantitative assessment overstated risk 
because the current toxicology database shows no evidence of adverse 
effects from exposure to imazapyr. Because EPA is not quantitatively 
assessing the risk of imazapyr based on a reliance on the use of safety 
factors, EPA has not retained the additional safety factor described in 
FFDCA section 408(b)(2)(C) for the protection of infants and children.
    Therefore, based on EPA's qualitative assessment of the imazapyr 
risk and the prior quantitative risk assessment discussed in the final 
rule published in the Federal Register of September 26, 2003 (68 FR 
55475) (FRL-7321-4), EPA concludes that there is a reasonable certainty 
that no harm will result to the general population, or to infants and 
children from aggregate exposure to imazapyr and its metabolites or 
degradates.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography with tandem 
mass spectrometric detection (LC/MS/MS)) is available to enforce the 
tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established MRLs for imazapyr on rapeseed, sunflower, or lentils.

[[Page 66653]]

C. Revisions to Petitioned-for Tolerances

    EPA is revising the tolerance expressions for plant and livestock 
commodities to clarify the chemical moieties that are covered by the 
tolerances and specify how compliance with the tolerances is to be 
measured. The revised tolerance expression makes clear that the 
tolerances cover ``residues of imazapyr, including its metabolites and 
degradates,'' as specified in FFDCA section 408(a)(3), and that 
compliance with the tolerance levels is to be determined by measuring 
only the residues of imazapyr [2-[4,5-dihydro-4-methyl-4-(1-
methylethyl)-5-oxo-1H-imidazol-2-yl]-3-pyridinecarboxylic acid]. EPA 
has determined that it is reasonable to make this change final without 
prior proposal and opportunity for comment because public comment is 
not necessary, in that the change has no substantive effect on the 
tolerance, but rather incorporates statutory requirements and is merely 
intended to clarify the existing tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of imazapyr [2-
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-3-
pyridinecarboxylic acid], in or on lentil at 0.2 ppm; rapeseed subgroup 
20A and sunflower subgroup 20B at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: October 22, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.500, paragraph (a) is amended by revising the 
introductory text and alphabetically adding the following commodities 
to the table to read as follows:


Sec.  180.500  Imazapyr; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide, imazapyr, including its metabolites and degradates, in or on 
the commodities in the following table. Compliance with the tolerance 
levels is to be determined by measuring only the residues of imazapyr 
[2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-3-
pyridinecarboxylic acid].

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Lentil \1\..............................................             0.2
 
                                * * * * *
Rapeseed subgroup 20A \1\...............................            0.05
 
                                * * * * *
Sunflower subgroup 20B \1\..............................            0.05
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\1\ There are no U.S. Registrations.

* * * * *
[FR Doc. 2013-26364 Filed 11-5-13; 8:45 am]
BILLING CODE 6560-50-P


